How to Leverage Your QMS to Streamline Regulatory Submissions
Overview
Regulatory submissions can make or break a startup in the pharmaceutical industry. The Drug Development process is filled with risks, and the approval to progress is never guaranteed. That’s why it’s crucial to invest in accurate submissions that represent the best knowledge and interpretations, addressing all strategic considerations. But we know it’s not an easy feat.
Imagine gaining invaluable tips and tricks to capture project knowledge and streamline your regulatory submission workflow. Picture yourself equipped with the tools to overcome the challenges of managing product and process knowledge across organizations, systems, and information silos. What if you could navigate the complexities of collaborating with multiple subcontractors and consultants with ease? It’s all within your reach.
Join us for a groundbreaking webinar featuring Raz Eliav, a leading expert in CMC Development and Regulatory Affairs. In this exclusive lecture, we will focus on the CDMO-Sponsor relationship and explore how to overcome the difficulties that arise during critical times like regulatory submissions and due diligence. We’ll reveal practical solutions using the Quality Management System (QMS), a regulatory requirement that is readily available to you.
By attending this webinar, you’ll:
1. Discover tips and tricks for using the eQMS system to capture project knowledge effectively.
2. Streamline your workflow of regulatory submissions, even when multiple subcontractors and consultants are involved.
3. Gain insights into leveraging the contextual framework of CTD Module 3 to make project knowledge available and concurrent as needed.
4. Learn how to structure your documents and utilize regulated workflows for concurrent review, saving you time and resources.
5. Uncover the power of the QMS as a tool for knowledge management and regulatory project management.
Don’t miss this opportunity to revolutionize your regulatory submission process and ensure your startup’s success. Register now to secure your spot and gain the knowledge that can propel your career in the pharmaceutical industry.
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Who Should Attend:
- QA Manager, QA Supervisor, QA/QC Specialist, Deviation Management Specialist, Change Control Specialist, Process Engineer, Validation Engineer, Regulatory Affairs, CMC Development
- Skill Level: Novice, Intermediate , Expert
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Topics:
- Overview
- Knowledge vs. Risk - how the Risk/benefit profile evolves throughout development
- The Regulatory paradigm and typical submission milestones
- CTD Module 3 - key elements
- The QMS as a Knowledge Management system - CTD Chapter breakdown pointing to common GMP documents
- The QMS as a Regulatory Project management system - common pitfalls and pain-points in Regulatory authoring processes and the importance of GDP (even if not officially required, i.e. during authoring)
- Present a Case study with Qualio
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Special event information:
- All participants will get a complimentary certificate of attendance courtesy of the webinar's partner- Qualio.
Speaker
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Raz EliavCMC Development and Regulatory Affairs ExpertRaz Eliav is the founder of Beyond CMC, on a mission to help startups in Drug Development leverage the existing knowledge, know-hows, and Data Technologies in reducing development risks, with a focus on the Drug Quality and Manufacturing aspects, known as CMC.
Raz provides strategic consulting and training courses in CMC Development, Operations, and Regulatory Affairs. With over 12 years of experience in all clinical development phases and diverse product modalities, mainly Biologicals and Advanced Therapies.
Partner
Qualio
Website
https://qualio.com/Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.
Additional Partners
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Beyond CMC
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Email
Office@BeyondCMC.com -
Website
https://www.beyondcmc.com/ -
https://www.linkedin.com/company/beyondcmc/
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If you attend the live session you will get a digital certificate of attendance emailed to you within 7-working days.
Yes, our event partners will email you the event recording within several weeks.
